Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

NCT06168799
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Phase
Phase 2
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Recruitment status
Completed
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Participants
271
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Lead sponsor
AM-Pharma
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Start date
2023-12-19
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Number of sites
1
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Summary
The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.
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Short title
Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery
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Official title
Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ilofotase Alfa in Patients at Risk for Renal Damage Following Open Heart Surgery
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-12-03
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First posted
2023-12-13
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Registry last updated
2025-12-15
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Primary completion date
2025-10-05
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Start date
2023-12-19
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Actual participants
271
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Participants
271
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Participant count basis
Actual
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Protocol amendments
5
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Randomisation ratio
1:1
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Number of sites
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AM-Pharma
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06168799
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ClinicalTrials.gov ID
NCT06168799
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Assessment of serum creatinine values

    Timeframe: From Baseline to Day 5

    Ratio between the highest value postsurgery (post-surgery Day 1 and Days 2, 3, 4, and 5) and the pre-surgery baseline value for serum creatinine

  1. Assessment of major adverse kidney events (MAKE) 60

    Timeframe: Daily post-surgery through Day 5

    Major adverse kidney events (MAKE) 60, defined as died up to and including Day 61, have received or are receiving new renal replacement therapy (RRT) up to and including Day 61, or have a decrease in estimated glomerular filtration rate (eGFR) ≥25% on Day 61 compared to the pre-surgery baseline eGFR reference value

  2. Assessment of adverse event (AE) and serious adverse event (SAE) occurrence

    Timeframe: From Day -1 to Day 28

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  1. Age ≥18 years

  2. Planned for one of the following types of open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB):

    1. 1. combined valve and CABG surgery; 2. aortic valve plus aortic root and/or ascending aorta (excluding aortic arch)
    2. CABG with 3 or more distal anastomoses

  3. Screening eGFR ≥25 mL/min/1.73m2 and ≤65 mL/min/1.73m2

  4. Female patients of childbearing potential agreeing to use effective contraception within IP treatment and 14 days thereafter

    Post-menopausal females do not require contraception during the trial.

  5. Male patients agreeing to refrain from donating sperm, use a male condom when having sexual intercourse and in case their partner is of childbearing potential they must agree to use adequate and effective contraception method (see inclusion criterion 4) within IP treatment and 14 days thereafter

The five most important Exclusion Criteria:

  1. Body weight ≤55 kg
  2. Known or suspected glomerulonephritis (other than diabetic kidney disease) or other systemic vasculitis
  3. Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery
  4. Known chronic liver disorder with Child-Pugh C classification
  5. Current planned (or scheduled) surgical intervention under conditions of circulatory arrest, including planned deep hypothermic circulatory arrest
Sources for eligibility
clinicaltrials.gov

  • Research siteMunich, Germany
Sources for sites
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Sources for references
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Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)